Chronic Hepatitis B Virus InfectionPhase 1NCT06159062
A Clinical Study of 162 in Subjects With Chronic Hepatitis B Virus Infection
A Phase 1 study testing 162 in people with Chronic Hepatitis B Virus Infection, run by Yangshengtang Co., Ltd at 1 site in Australia.
Trial summary
The goal of this intervention research is to learn about the safety and tolerability of 162 with a single ascending dose in subjects with chronic hepatitis B virus (HBV) infection. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B Virus Infection
- What is being tested?
- 162
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteAustralia
- Study dates
- 3 Jun 2024to 9 Jul 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Able and willing to provide written informed consent and to comply with the study protocol according to ICH and local regulations.
- 2. Positive serum HBsAg and/or HBV DNA status for > 6 months prior to screening (two documented positive HBsAg and/or HBV DNA tests at least 6 months apart, one of which is at screening) or previous liver biopsy results with chronic HBV infection.
- 3. On Nucleos(t)ide analogs therapy for at least 3 months without an interruption of 7 or more consecutive days before the screening, and expected to remain on the same Nucleos(t)ide analogs for the duration of study participation.
- 4. 500 ≤ HBsAg ≤ 3,000 IU/mL, HBV DNA ≤ 20 IU/mL and ALT ≤ 3×ULN. 5. A male subject must agree to use adequate contraception from screening through at least 24 weeks after the dose of investigational product. Refer to Section 5.5 for more information on highly effective methods of contraception.
- 6. Women of childbearing potential must have a negative pregnancy test prior to the dosing administration, and agree to use adequate contraception from screening through at least 24 weeks after the dose of investigational product. A female subject of non-childbearing potential will have had at least 12 continuous months of natural (spontaneous) amenorrhoea, follicle stimulating hormone (FSH) level > 40 mIU/mL at screening, and an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms); or have had surgical bilateral oophorectomy, hysterectomy or bilateral tubal ligation beyond 6 weeks prior to screening. Refer to Section 5.5 for more information on highly effective methods of contraception.
Who cannot join
- 1. Patients who had history of anaphylaxis against the active ingredients or excipients of the investigational product 162.
- 2. History of allergic reactions to monoclonal antibodies or antibody fragments.
- 3. History or presence of clinical significant liver disease other than chronic HBV infection (e.g., autoimmune hepatitis, alcoholic liver disease, non-alcoholic steatohepatitis).
- 4. Patients who have impaired cardiac function or clinically significant cardiac diseases, including any of the following: New York Heart Association class III-IV for cardiac insufficiency； Patients with poorly controlled arrhythmia: QTc interval > 480 ms calculated by Fridericia's formula, or congenital syndrome of prolonged QT interval; Any of the following within 6 months prior to the screening: myocardial infarction, severe or unstable angina, congestive heart failure, cerebrovascular accident (including transient ischemic attack), symptomatic pulmonary embolism or other clinically significant thromboembolic disease, or coronary artery bypass graft; Patients with other clinically significant cardiovascular disease who were assessed as unsuitable for this study by the investigator.
- 5. Patients with uncontrolled hypertension (systolic blood pressure ≥ 150 mm Hg and/or diastolic blood pressure ≥ 100 mm Hg) or previous hypertensive crisis or hypertensive encephalopathy.
- 6. Patients with other active infections other than HBV infection requiring continual treatment with antibiotics or antivirals (except for clinically insignificant temporary infection such as cold), or positive for hepatitis C virus (HCV) or human immunodeficiency virus (HIV) antibodies at screening.
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- 7. Patients with history of hepatitis A virus (HAV), hepatitis D virus (HDV) or hepatitis E virus (HEV).
- 8. Patients with history of malignant tumor within 5 years except cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of uterine cervix.
- 9. History or presence of immune-mediated diseases, including but not limited to idiopathic thrombocytopenic purpura, systemic lupus erythematosus, rheumatoid arthritis.
- 10. Liver biopsy, Fibroscan or equivalent test obtained within the past 6 months demonstrating liver with evidence of progressive fibrosis or cirrhosis ( Metavir 3, recommended cut-off for fibroscan 8.5 kPa).
- 11. Evidence of liver cirrhosis or decompensated liver disease such as Child-Pugh Class B or C, ascites, esophageal or gastric varices, hepatic encephalopathy or portal hypertension.
- 12. History of or suspicion of hepatocellular carcinoma or alpha fetoprotein (AFP) > 50 ng/mL at screening.
- 13. History of allogenic transplantation of organs, bone marrow or stem cell. 14. Any other concomitant disease, condition or treatment that could interfere with the conduct of the study or that would, in the opinion of the Investigator or Sponsor, pose an unacceptable risk to the subject in the study or interfere with the interpretation of study data.
- 15. Those who received blood transfusion, albumin, recombinant human thrombopoietin, or colony-stimulating factor therapy within 2 weeks prior to screening 16. Patients who have not sufficient baseline organ function and whose laboratory data meet the following criteria at enrollment: Absolute neutrophil count (ANC) < 2.0×109/L; Serum albumin < 35 g/L; Total bilirubin > 1.5×ULN; International normalized ratio (INR) > 1×ULN; Hemoglobin < 100 g/L; Platelets < 80×109/L; Creatinine clearance < 50 mL/min. 17. Patients who had received an immunosuppressant, immunity-modifying drug (e.g., interferon, thymosin agents), cytotoxic chemotherapy that can affect their immune system, or radiation therapy within 6 months prior to the dosing of investigational product, except for the following treatments: a) topical or inhaled corticosteroids; b) short-term (treatment duration up to 7 days) use of systemic glucocorticoids for prevention or treatment of non-autoimmune allergic diseases.
- 18. Those who have received live or attenuated vaccines (e.g., measles, mumps, rubella, varicella, yellow fever, rabies, BCG, typhoid vaccine, etc.) within 4 weeks before screening, or any covid-19 vaccine within 2 weeks before screening.
- 19. Those who underwent major surgery within 4 weeks before screening, or plan to undergo major surgery during the study.
- 20. Those who are participating in other clinical studies, or currently not participating in a study and have been dosed in another clinical study 4 weeks prior to screening, or previous treatment with an investigational agent for chronic HBV infection 6 months prior to screening.
- 21. Pregnant or lactating women. 22. Those who are determined disqualified to join clinical studies by investigator for other causes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 162 With a Single Ascending Dose in Subjects With Chronic Hepatitis B Virus Infection
The goal of this intervention research is to learn about the safety and tolerability of 162 with a single ascending dose in subjects with chronic hepatitis B virus (HBV) infection.
Read the detailed description
This is a multi-center, randomized, double-blind and placebo-controlled dose escalation study design.
The dose-escalation stage will be conducted sequentially at 3 dose cohorts, which are 50 mg in the pre-test, 75 mg and 100 mg in the formal test.
Two subjects with chronic HBV infection will be enrolled in the 50 mg dose cohort and all will be given the investigational product 162.
Four subjects with chronic HBV infection will be enrolled in the 75 mg and 100 mg dose cohorts, respectively. Subjects in each cohort will be randomized 3:1 to receive a single ascending dose of 162 or placebo.
- Conditions
- Chronic Hepatitis B Virus Infection
- Being tested
- 162, Placebo
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
162Drug
The investigational product 162 is a novel monoclonal antibody targeting HBsAg.
PlaceboDrug
Placebo do not consist any active ingredients.
| Study group | Role | What they receive |
|---|---|---|
| 162 | Experimental | The dose-escalation stage will be conducted sequentially at 3 dose cohorts, which are 50 mg in the pre-test, 75 mg and 100 mg in the formal test.
Two subjects with chronic HBV infection will be enrolled in the 50 mg dose cohort and all will be given the investigational product 162.
Four subjects with chronic HBV infection will be enrolled in the 75 mg and 100 mg dose cohorts, respectively. Subjects in each cohort will be randomized 3:1 to receive a single ascending dose of investigational product 162 or placebo. Receives: Drug: 162 |
| Placebo | Placebo comparator | The dose-escalation stage will be conducted sequentially at 3 dose cohorts, which are 50 mg in the pre-test, 75 mg and 100 mg in the formal test.
Two subjects with chronic HBV infection will be enrolled in the 50 mg dose cohort and all will be given the investigational product 162.
Four subjects with chronic HBV infection will be enrolled in the 75 mg and 100 mg dose cohorts, respectively. Subjects in each cohort will be randomized 3:1 to receive a single ascending dose of investigational product 162 or placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event (consists of dose limited toxicity)
incidence and severity of adverse events
Measured: From the participant receives the investigational product to 28 days after the investigational product administered
Secondary outcomes (6)
Area under the concentration curve
Area under the concentration curve
Measured: Within 30 minutes before the dosing administration to 648 hours after the start of the dosing administration
Maximum concentration
Maximum plasma concentration of 162
Measured: Within 30 minutes before the dosing administration to 648 hours after the start of the dosing administration
Half-life
Half-life fo 162 eliminates from plasma
Measured: Within 30 min before the dosing administration to 648 h after the start of the dosing administration
Time of maximum concentration
Time of maximum concentration of 162 in plasma
Measured: Within 30 minutes before the dosing administration to 648 hours after the start of the dosing administration
Concentration of serum Hepatitis B surface antigen (HBsAg)
The concentration of serum Hepatitis B surface antigen (HBsAg)
Measured: Within 30 minutes before the dosing administration to 648 hours after the start of the dosing administration
Concentration of serum Hepatitis B virus DNA
The concentration of serum Hepatitis B virus DNA
Measured: Within 30 minutes before the dosing administration to 648 hours after the start of the dosing administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start3 Jun 2024
- Primary completion9 Jul 2024
- Study completion9 Jul 2024
Why it stopped: Enrollment difficulty
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis B Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yangshengtang Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159062
- Sponsor's protocol ID
- YST-162-102
- Status last verified
- Jul 2024
- First submitted
- 20 Nov 2023
- Last updated
- 16 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo-controlled Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 162 With a Single Ascending Dose in Subjects With Chronic Hepatitis B Virus Infection
- ClinicalTrials.gov ID
- NCT06159062
- Acronym / sponsor ID
- YST-162-102
- Conditions
- Chronic Hepatitis B Virus Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment difficulty
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Yangshengtang Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 9 Jul 2024 (actual)
- Study completion
- 9 Jul 2024 (actual)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this intervention research is to learn about the safety and tolerability of 162 with a single ascending dose in subjects with chronic hepatitis B virus (HBV) infection.
Detailed description
This is a multi-center, randomized, double-blind and placebo-controlled dose escalation study design.
The dose-escalation stage will be conducted sequentially at 3 dose cohorts, which are 50 mg in the pre-test, 75 mg and 100 mg in the formal test.
Two subjects with chronic HBV infection will be enrolled in the 50 mg dose cohort and all will be given the investigational product 162.
Four subjects with chronic HBV infection will be enrolled in the 75 mg and 100 mg dose cohorts, respectively. Subjects in each cohort will be randomized 3:1 to receive a single ascending dose of 162 or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 162 | Experimental | Drug: 162The dose-escalation stage will be conducted sequentially at 3 dose cohorts, which are 50 mg in the pre-test, 75 mg and 100 mg in the formal test. Two subjects with chronic HBV infection will be enrolled in the 50 mg dose cohort and all will be given the investigational product 162. Four subjects with chronic HBV infection will be enrolled in the 75 mg and 100 mg dose cohorts, respectively. Subjects in each cohort will be randomized 3:1 to receive a single ascending dose of investigational product 162 or placebo. |
| Placebo | Placebo comparator | Drug: PlaceboThe dose-escalation stage will be conducted sequentially at 3 dose cohorts, which are 50 mg in the pre-test, 75 mg and 100 mg in the formal test. Two subjects with chronic HBV infection will be enrolled in the 50 mg dose cohort and all will be given the investigational product 162. Four subjects with chronic HBV infection will be enrolled in the 75 mg and 100 mg dose cohorts, respectively. Subjects in each cohort will be randomized 3:1 to receive a single ascending dose of investigational product 162 or placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Able and willing to provide written informed consent and to comply with the study protocol according to ICH and local regulations.
- 2. Positive serum HBsAg and/or HBV DNA status for > 6 months prior to screening (two documented positive HBsAg and/or HBV DNA tests at least 6 months apart, one of which is at screening) or previous liver biopsy results with chronic HBV infection.
- 3. On Nucleos(t)ide analogs therapy for at least 3 months without an interruption of 7 or more consecutive days before the screening, and expected to remain on the same Nucleos(t)ide analogs for the duration of study participation.
- 4. 500 ≤ HBsAg ≤ 3,000 IU/mL, HBV DNA ≤ 20 IU/mL and ALT ≤ 3×ULN. 5. A male subject must agree to use adequate contraception from screening through at least 24 weeks after the dose of investigational product. Refer to Section 5.5 for more information on highly effective methods of contraception.
- 6. Women of childbearing potential must have a negative pregnancy test prior to the dosing administration, and agree to use adequate contraception from screening through at least 24 weeks after the dose of investigational product. A female subject of non-childbearing potential will have had at least 12 continuous months of natural (spontaneous) amenorrhoea, follicle stimulating hormone (FSH) level > 40 mIU/mL at screening, and an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms); or have had surgical bilateral oophorectomy, hysterectomy or bilateral tubal ligation beyond 6 weeks prior to screening. Refer to Section 5.5 for more information on highly effective methods of contraception.
Key exclusion criteria (18 listed)
- 1. Patients who had history of anaphylaxis against the active ingredients or excipients of the investigational product 162.
- 2. History of allergic reactions to monoclonal antibodies or antibody fragments.
- 3. History or presence of clinical significant liver disease other than chronic HBV infection (e.g., autoimmune hepatitis, alcoholic liver disease, non-alcoholic steatohepatitis).
- 4. Patients who have impaired cardiac function or clinically significant cardiac diseases, including any of the following: New York Heart Association class III-IV for cardiac insufficiency； Patients with poorly controlled arrhythmia: QTc interval > 480 ms calculated by Fridericia's formula, or congenital syndrome of prolonged QT interval; Any of the following within 6 months prior to the screening: myocardial infarction, severe or unstable angina, congestive heart failure, cerebrovascular accident (including transient ischemic attack), symptomatic pulmonary embolism or other clinically significant thromboembolic disease, or coronary artery bypass graft; Patients with other clinically significant cardiovascular disease who were assessed as unsuitable for this study by the investigator.
- 5. Patients with uncontrolled hypertension (systolic blood pressure ≥ 150 mm Hg and/or diastolic blood pressure ≥ 100 mm Hg) or previous hypertensive crisis or hypertensive encephalopathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 162The investigational product 162 is a novel monoclonal antibody targeting HBsAg. | Drug | 162 |
| PlaceboPlacebo do not consist any active ingredients. | Drug | Placebo |
Primary outcome
Adverse event (consists of dose limited toxicity)
Time frame: From the participant receives the investigational product to 28 days after the investigational product administered
incidence and severity of adverse events
6 secondary outcomes
Area under the concentration curve
Time frame: Within 30 minutes before the dosing administration to 648 hours after the start of the dosing administration
Maximum concentration
Time frame: Within 30 minutes before the dosing administration to 648 hours after the start of the dosing administration
Half-life
Time frame: Within 30 min before the dosing administration to 648 h after the start of the dosing administration
Time of maximum concentration
Time frame: Within 30 minutes before the dosing administration to 648 hours after the start of the dosing administration
Concentration of serum Hepatitis B surface antigen (HBsAg)
Time frame: Within 30 minutes before the dosing administration to 648 hours after the start of the dosing administration
Concentration of serum Hepatitis B virus DNA
Time frame: Within 30 minutes before the dosing administration to 648 hours after the start of the dosing administration
Results and safety
The study was stopped early (reason given: Enrollment difficulty). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 162 in people with Chronic Hepatitis B Virus Infection, run by Yangshengtang Co., Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Enrollment difficulty). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event (consists of dose limited toxicity) (time frame: From the participant receives the investigational product to 28 days after the investigational product administered). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.